ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT

K971602 · Beckman Instruments, Inc. · DHR · Jun 27, 1997 · Immunology

Device Facts

• Record ID: K971602
• Device Name: ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DHR · Immunology
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Array® Systems Rheumatoid Factor (RF upe) reagent, when used in conjunction with the Beckman Array System and Beckman Calibrator 5 Plus, is intended for quantitative determination of human rheumatoid factor by rate nephelometry.

Device Story

The Array Systems Rheumatoid Factor (RFMPE) Reagent is an in vitro diagnostic reagent used with the Beckman Array System and Beckman Calibrator 5 Plus. It utilizes rate nephelometry to measure rheumatoid factor concentrations in human serum. The device employs latex-coated particles to facilitate the immunochemical reaction. The system measures light scatter at a 70° angle at a reaction temperature of 26.7°C. The analytical range is 20 to 600 IU/mL. The device is intended for use by laboratory professionals in a clinical setting. Results are used by clinicians to aid in the diagnosis of rheumatoid arthritis. The device provides quantitative data to support clinical decision-making regarding patient disease state.

Clinical Evidence

Bench testing only. Performance was validated through method comparison against the IMMAGE System RF Reagent. Imprecision studies were conducted with 160 replicates per level. Within-run imprecision (%CV) ranged from 2.69% to 3.56% across levels (30.2 to 564 IU/mL). Total imprecision (%CV) ranged from 3.17% to 5.16%.

Technological Characteristics

Reagent utilizes latex-coated particles for immunochemical reaction. Measurement principle is rate nephelometry. Measurement angle: 70°. Reaction temperature: 26.7°C. Analytical range: 20-600 IU/mL. Shelf-life: 24 months at 2-8°C. System is designed for use with Beckman Array Systems.

Indications for Use

Indicated for the quantitative determination of human rheumatoid factor in human serum samples to aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent (K963048)

Submission Summary (Full Text)

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# BECKMAN

JUN 27 1997

Summary of Safety & Effectiveness Array® Systems Rheumatoid Factor (RFupe) Reagent

K971602

#### 1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

30 April 1997

#### 3.0 Device Name(s):

### 3.1 Proprietary Names

Array® Systems Rheumatoid Factor (RFMPE) Reagent

### 3.2 Classification Names

Rheumatoid factor immunological test system(21 CFR 866.5775)

#### 4.0 Predicate Device(s):

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent K963048

#### 5.0 Description:

The Array Systems Rheumatoid Factor (RFupe) Reagent is designed for optimal performance on Beckman's Array® Systems. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum samples.

#### 6.0 Intended Use:

The Array® Systems Rheumatoid Factor (RF upe) reagent, when used in conjunction with the Beckman Array System and Beckman Calibrator 5 Plus, is intended for quantitative determination of human rheumatoid factor by rate nephelometry.

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Beckman Instruments, Inc., Section 510(k) Notification Array® Systems Rheumatoid Factor (RFMPE) Reagent Summary of Safety & Effectiveness

#### 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
|--------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | SIMILARITIES | |
| | Intended use | |
| | Nephelometric principle | |
| Array Systems<br>RFMPE Reagent | Latex coated particles | Same as IMMAGE System RF<br>Reagent |
| | Shelf-life of 24 months<br>(stored at 2-8°C) | |
| | Calibrator<br>(Beckman Calibrator 5 Plus) | |
| | DIFFERENCES | |
| Array Systems<br>RFMPE Reagent | Angle of measurement | The Array System measures at<br>a 70° angle while the IMMAGE<br>System measures at a 90°<br>angle |
| Array Systems<br>RFMPE Reagent | Initial analytic range | The initial analytic range for<br>Array is 20 to 600 IU/mL while<br>the IMMAGE System is 20 to<br>800. |
| Array Systems<br>RFMPE Reagent | Reaction temperature | The Array Systems measure at<br>26.7°C while the IMMAGE<br>System measures at 37°C |

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Beckman Instruments, Inc., Section 510(k) Notification Array® Systems Rheumatoid Factor (RFMPE) Reagent Summary of Safety & Effectiveness

#### Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that results obtained from the Array RFMPE Reagent to the IMMAGE System RF Reagent.

### Method Comparison Study Results Array RFMPE Reagent vs. IMMAGE RF Reagent

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## Stability Study Results

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### Estimated Array RFMPE Reagent Imprecision

| Sample | Mean (IU/mL) | S.D. (IU/mL) | %C.V. | N |
|------------------------|--------------|--------------|-------|-----|
| Within-Run Imprecision | | | | |
| Level 1 | 30.2 | 1.07 | 3.56 | 160 |
| Level 2 | 313 | 8.71 | 2.78 | 160 |
| Level 3 | 564 | 15.2 | 2.69 | 160 |
| Total Imprecision | | | | |
| Level 1 | 30.2 | 1.56 | 5.16 | 160 |
| Level 2 | 313 | 10.4 | 3.32 | 160 |
| Level 3 | 564 | 17.9 | 3.17 | 160 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92822-8000

JUN 2 7 1997

Re: K971602 Trade Name: Array® Systems Rheumatoid Factor(RFME) Reagent Regulatorv Class: II Product Code: DHR Dated: April 30, 1997 Received: May 01, 1997

Dear Ms. Hellie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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# Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page *_ of _*

510(k) Number (if known):

510(k) Number (if known):

Device Name: Array® Systems Rheumatoid Factor (RFMPE) Reagent

Indications for Use:

The Array® Systems Rheumatoid Factor (RFME) reagent, when used in conjunction with the Beckman Array System and Beckman Calibrator 5 Plus, is intended for quantitative determination of human rheumatoid factor by rate nephelometry.

Rheumatoid factor immunological test system(21 CFR 866.5775)

(a) Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure bv immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

(b) Classification. Class II (performance standards).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Petie E. Mahon

aboratory Devices

Prescription Use & (per 21 CFR 801.109)

OR

Over-the-Counter Use Optional Format 1-2-96